2007年国产药品批准情况分析

Analysis for the approved domestic drugs in 2007

2007年我国出台了一系列医药政策,对药品注册工作产生了深远的影响。为更好地指导企业药品研发及注册工作,对中国医药信息网2007年《国产药品品种数据库》的数据进行了分析。分析发现:2007年药品批准数量大幅减少,但年底出现回升趋势;与仿制药相比,新药比重略有下降;中药批准比重显著下降,化学药品比重上升;地区间药品注册批件数量不平衡;当前企业的研发重点仍集中在大的治疗领域。

A series of polices promulgated in 2007 have brought important effects on drug registration. In order to direct drug R＆D and drug registration, we analyzed the data of Domestic Drug Database in China Pharmaceutical Network （www. cpi. gov. cn）. The results are as follows： the number of the approved drugs was reduced, but appeared to be increased at the end of 2007 ; as compared with generic drugs, the proportion of new.drugs was lowered ; the approved TCMs were dramatically reduced but the approved chemical drugs were increased; there was an imbalance in the approval licenses issued among provinces; the current focus for drug R＆D was still on main therapeutic areas.